The following data is part of a premarket notification filed by Cortex Biophysik Gmbh with the FDA for Metalyzer, Model 2; Metalyzer, Model 3.
| Device ID | K993641 |
| 510k Number | K993641 |
| Device Name: | METALYZER, MODEL 2; METALYZER, MODEL 3 |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | CORTEX BIOPHYSIK GMBH 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward CORTEX BIOPHYSIK GMBH 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-28 |
| Decision Date | 2000-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 74250179233555 | K993641 | 000 |